Limiflex Dynamic Sagittal Tether

Primary DI
00859373004005
Brand
Limiflex Dynamic Sagittal Tether
Company
EMPIRICAL SPINE, INC.
Model
Gen 3
Catalog number
KLF-3001
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SGKProsthesis, Spinous Process Tension Band Implant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGKProsthesis, Spinous Process Tension Band ImplantUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P220031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P220031000LimiFlex Dynamic Sagittal TetherEmpirical Spine, Inc.2026-02-12SGK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859373004005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859373004005008593730040058593730040050859373004005

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar decompression interspinous spacerA device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included with the device.

Regulatory Flags#

DUNS number
092942368
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859373004012Limiflex Dynamic Sagittal Tether Instrument SetGen 3KLI-30012026-03-27
00859373004029PasserGen 3LI-30012026-03-27
00859373004036HolderGen 3LI-30022026-03-27
00859373004043Symbol PlateGen 3LI-30032026-03-27
00859373004050DriverGen 3LI-30042026-03-27
00859373004067Tensioner ClipGen 3LI-30052026-03-27
00859373004074TensionerGen 3LI-30062026-03-27
00859373004081Instrument TrayGen 3LI-30072026-03-27